Efficacy and Safety of Using G-CSF on Day before Stem Cell Infusion (Day -1) in Hematopoietic Stem Cell Transplantation (HSCT) -A Single Institution Experience from India.

Background: It is well established that recombinant human G-CSF accelerates neutrophil recovery following hematopoietic stem cell transplantation. However, the optimal timing of G-CSF following transplantation remains unknown. We have done a Phase II non randomized open label study on effects of adding an extra dose of G-CSF (filgrastim 5μgm/kg) on Day -1 of HSCT.

Patients and methods: Thirty nine consecutive patients who underwent HSCT in one year period were given G-CSF on Day -1(Day before stem cell infusion) in addition to the regular doses from Day +1 till engraftment.

Results: Among the 39, males were 31 and females 8 with 15 allograft and 24 autografts. The type of harvest was PBSC in 35, BM alone in 1and both in 3 cases. Disease wise distribution was AML-11, MM-8, NHL-6, HL-5, CML-4, MDS-2 and Aplastic Anemia, ALL and Ca nasopharynx 1 each. The median MNC and CD 34 doses infused were 5.4X10⁸/Kg and 2.26X10⁶/Kg respectively. Median days of Grade IV neutropenia was 11 (range 5–19) and that of ANC< 100 was 6 (range 2–19). Neutropenic fever was present for a median of 10 days (range 4–19). Neutrophil engraftment and platelet engraftment occurred at Day +11(range 8–13) and Day +21(range 11–73) respectively. Median number of packed cells and platelets (SDP) transfused were 4 and 5 respectively. Mucositis was present for a median of 9 days with Grade III in 51% (n=20) and Grade IV in 23% (n=9) patients. TPN was used in 76% (n=30) patients for a median days of 6 days. Median number of days of antibiotics use was 10 and 57% (n=22) needed 3 lines of antibiotics. Antifungals were used in 57% (n=22) and 95% of use was empirical. Infections were documented in 42% (n=16). Median days of hospitalization was 22 (range 13–38). Transplant related mortality was 10% (2 Auto and 2 Allo). After a median follow up of 113 days 79.71% (n=34) patients are alive with 71% (n=28) in complete remission. One patient with Ca nasopharynx had progressive disease on evaluation and one patient with peripheral T cell lymphoma developed a secondary leukemia (myeloid) post transplant.

Conclusions: Addition of G-CSF on Day -1 of HSCT is safe and provides stable engraftment and acceptable results in terms of neutropenic fever, requirement of blood products, antibiotics, TPN and duration of hospital stay. It needs to be compared in randomized trials with use of G-CSF from Day +1 onwards to prove its superiority over that schedule.